FDA-Device2012-10-03Class II
Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma.
Neomend Inc
Hazard
Product was distributed with an incorrect expiration date. Product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09.
Sold states
US Nationwide Distribution
Affected count
95 units
Manufactured in
60 Technology Dr, N/A, Irvine, CA, United States
Products
Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2454-2012Don't want to check this manually?
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